Merck Serono Spa
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Italy
- Registered address
- VIA LUIGI EINAUDI 11, Guidonia Montecelio, Roma 00012, Italy (ITA)
- Operations here
- analysis
- FDA identifiers
- FEI 3002807252 · DUNS 339654002
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2019-03-29
- NAIDrug Quality Assurance2017-07-28
- NAIDrug Quality Assurance2015-02-20
- VAIDrug Quality Assurance2013-03-14
- OAIDrug Quality Assurance2011-07-01
- NAIDrug Quality Assurance2009-04-30
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- pegflilgrastim-fpgkFresenius Kabi USA, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.